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PART V INTERMEDIATE TECHNOLOGIES IN MEDICALLY BASED PREVENTION TRIALS
Pages 41-46

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From page 41...
... For any medically based prevention trial to work, however, a partnership is needed among three groups: biomedical scientists, social and behavioral scientists, and target communities. If the social and behavioral issues regarding trial design, recruitment, informed consent, adherence to protocols, and evaluation of outcomes are not addressed, the trials can be undermined so that they are not successful or valid.
From page 42...
... Engaged opinion leaders in the community can help change misperceptions, gain community acceptance, and avoid errors in the field trial design. Even if community leaders become interested in participating, the people at risk for HIV still need to be informed and recruited.
From page 43...
... Minimizing potential social harms when researchers go into communities and enroll people in HIV prevention trials will be important in the ethical contract established between scientist and volunteer. Conducting research on "social harm reduction" before trials get underway can help to facilitate medically based prevention trials in communities.
From page 44...
... If participants in a vaccine trial incorrectly assume that they are protected from infection, they may increase their risky behavior, compromising their welfare and the researchers' ability to interpret the results. Another example points out the need to study the mobility of people as they move in and out of their communities: a community-wide program to control sexually transmitted diseases can be undermined if people outside the community who have sexually transmitted diseases come into the community and reinfect it.
From page 45...
... From the social sciences, knowledge regarding external political and legal constraints on individual action, networks, diffusion, behavior change, and education is incorporated into the intervention and data interpretation. This type of intervention asks society to make a major policy change by allowing the legal exchange of needles, and asks individuals to make themselves available publicly to the needle "exchanger" and to make behavior changes through regular needle exchanges.
From page 46...
... has recognized the critical importance of community preparedness and social harm reduction in vaccine research and is sponsoring suitable behavioral research in collaboration with other NIH institutes and with the CDC. In addition, NIAID has initiated support for a broad range of prevention research initiatives aimed at answering immediate research questions while building vital experience in anticipation of HIV vaccine efficacy trials.


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